Surgical hand piece with dual lumen work tip for use with infusion cannula

ABSTRACT

A surgical hand piece has a source of ultrasonic energy provided to a connecting body having a first passage with one end to receive fluid from a first source and the other end at the connecting body distal end. A work tip has first and second tubes each having at least one opening at its distal end and the proximal end of one or both of the tubes connected to the connecting body distal end to receive the ultrasonic energy and to selectively receive or discharge fluid from either the first or second source as controlled by a valve. A cannula is provided which is adapted to be placed in an opening in the cornea through which the work tip extends during the removal of cataracts from the eye by phacoemulsification. The cannula may be equipped with channels that permit additional infusion of fluid into the eye during the procedure, which infusion also cools the surrounding corneal tissue to protect against heat generated by the ultrasonic vibration of the work tip.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/142,555, filed on Dec. 27, 2013, which is a continuation-in-part ofprior U.S. patent application Ser. No. 12/215,315 filed on Jun. 26, 2008(now U.S. Pat. No. 8,641,658, which issued Feb. 4, 2014).

TECHNICAL FIELD

The present invention is generally directed to an ultrasonic surgicalhand piece with a dual lumen work tip that is disposable, and can beused for the removal of cataracts from the eye of a patient byphacoemulsification.

BACKGROUND OF THE INVENTION

The use of ultrasonic instruments in surgical applications is wellknown. One widely used type of instrument is an ultrasonic hand piecethat is used in ophthalmic applications, such as in the removal ofcataracts from the eye by phacoemulsification.

FIG. 6 depicts one such type of prior art ultrasonic hand piece as shownin U.S. Pat. No. 4,504,264 of Kelman. This hand piece has a housing 10of, for example, plastic or metal, within which is supported atransducer means 11 for generating mechanical vibrations upon excitationwith an alternating-current electrical signal. The transducer 11 isshown as a magnetostrictive transducer with an electrical coil 12 woundabout a stack of metal laminations so that longitudinal mechanicalvibrations are produced. The transducer can also be of the piezoelectrictype. There is a connecting body 16 of, for example, titanium, having areduced diameter distal end portion, which also can be an attachedseparate portion. The connecting body forms an acoustic impedancetransformer for conveying the longitudinal vibrations of the transducer11 for application to an operative tool or working tip 14 connected tothe distal end of the connecting body 16.

The work tip 14 is at least partially external of the housing 10. It isconnected, such as by a screw thread, to the narrowed distal end of theconnecting body 16 so as to be coupled to the transducer 11. As aresult, the work tip is longitudinally vibrated by the transducer. Theworking tip 14 is an elongated, hollow tip of a suitable metal, such astitanium, that is capable of supporting ultrasonic vibrations. It has adistal end of a desired shape to be placed against the tissue to beremoved. The work tip 14 has a base portion 15 in threaded engagementwith the distal end of the connecting body 16. The tip 14 can beinterchanged by use of the screw threads.

The distal end of the tip 14 is shown surrounded by a sleeve 17, whichmay be made of a material such as silicone, whose proximal end 18 issupported in threaded engagement on a reduced diameter end of thehousing 10. If desired, the proximal end of sleeve 17 can be engagedmore proximally along the length of the housing 10. The connecting body16 has two elastomeric O-rings 19, 20 on its outer surface. Theseprovide a fluid-tight seal between the connecting body 16 and thetransducer means 11. A plurality of screws 51 are shown disposed aroundthe axis of the housing 10 for preventing longitudinal displacement(other than vibration) or rotational movement of the vibratory structurewithin the housing and also for radial centering of the vibratorystructure within the housing. Other types of conventional mountingarrangements can be used.

The hand piece also illustratively has electrical input terminals 40, 41for applying a suitable electrical signal to the magnetostrictivetransducer 11. Cooling water is shown provided inside the housing 10from an inlet 42 to an outlet 43 and within a chamber between O-ring 19and a grommet 50 for circulation around the transducer. This is notalways necessary and is not used in most present day hand pieces.

The sleeve 17 around the tip 14 forms a first fluid passage 21 betweenthe tip 14 and the sleeve for an irrigation fluid. An inlet 22 isprovided on the housing or sleeve distally of the O-ring 20 forsupplying the irrigation fluid to the passage 21 from a fluid supply,e.g., a bag of saline solution (not shown).

A passage 23 is formed through the connecting body 16 that is incommunication with a central passage 25 of the work tip 14. An outlet 24on the housing or sleeve receives a suction (aspiration) force that isapplied to the passage 23 in the connecting body and the central passage25 in the work tip. A chamber 31 is formed between the spaced O-rings19, 20 on the body 16 and the housing 10, with which the aspirationforce from outlet 24 communicates. Thus the aspiration force is from thesource (e.g., a suction pump not shown), into the chamber 31 between theO-rings, through the passage 23 in the connecting body and the passage25 in the work tip 14. Tissue that is emulsified by the work tip isaspirated from the operating site by the aspiration flow force. Inparticular, saline solution introduced into the eye through fluidpassage 21 and tissue displaced by the vibration force of the tip 14, isdrawn into the distal end of passage 25 and passes out of the hand piecethrough outlet 24. It should be noted that passage 25 is locatedconcentrically within passage 21.

As indicated, other apparatus (not shown) for use with the hand pieceinclude the suction pump for producing the aspiration fluid (suction),the treatment fluid supply (irrigation fluid, such as a saline liquid),an oscillator for applying an electrical signal to the vibratorystructure and control apparatus therefore. All of these are ofconventional construction.

Considering now the operation of the hand piece of FIG. 6. When anelectrical signal having a frequency of, for example, 40,000cycles/second is applied to the coil 12 around the magnetostrictivetransducer 11, the transducer 11 vibrates longitudinally at 40,000cycles per second, thereby vibrating the connecting bodies 13, 16 andthe work tip 14. Treatment fluid is supplied through inlet 22 and fluidpassage 21 to bathe the tissue in the operating site region around theworking tip 14. Suction force is applied through inlet 24 and passage 23to the working tip 14 passage 25 to withdraw the tissue fragmented bythe work tip along with some of the treatment fluid.

Instruments of the type described above are often used in cataractsurgery in which the eye lens is removed from the eye capsule and anintra-ocular lens (IOL) is then implanted. In such a procedure beforethe IOL is implanted it has been found to be desirable to cleanup lenssubstance and lens epithelial cells (LEC's) in the capsular bag of theeye and to remove them. Doing this procedure provides a more stable andlong-term fixation for certain types of IOL's in the capsular bag. Onemanner of accomplishing the cleanup is to use a combination ofirrigation of the capsular bag interior with a liquid together with theapplication of low power ultrasonic energy. This dislodges the unwantedcells and substances so that they can be removed from the capsular bagby the aspiration fluid flow.

In a cleanup procedure it is advantageous if the flow of the irrigationliquid can be made more directional than would be possible using thehand piece with the outer sleeve through which the liquid flows andexits from around the work tip that produces the ultrasonic energy. Itis also better if the aspiration force is lower. As a result, typicallya different tip from the one illustrated in FIG. 6, which breaks up thetissue, is used for the cleanup. In fact a completely differentinstrument called an infusion/aspiration (I/A) instrument is often usedfor this purpose. The I/A instrument has concentric infusion andaspiration lumens, but may have no ultrasonic vibration capability.Thus, when the phacoemulsification has been completed and cleanup is tobe started, the surgeon must remove the phacoemulsification tool fromthe eye. Then the surgeon removes the first or phacoemulsification worktip, replaces it with a different cleanup work tip and then inserts thenew work tip or a separate I/A tool in to the eye. This second insertioninto the eye increases the possibilities of infection and trauma. Also,the A/I tool has a disadvantage in that the surgeon would have to keepinserting and withdrawing the ultrasonic work tip and the I/A tool fromthe eye. As a result, this would also subject the patient to theincreased possibilities of infection and trauma.

As shown in the present inventor's own U.S. Pat. No. 7,083,589, thesurgical instrument may be provided with a coupler body located betweenthe connecting body and the work tip. In such a case the aspirationfluid flow is provided from the work tip aspiration passage through thecoupler to an outlet without coming into contact with the interior ofthe connecting body. Irrigation fluid can be provided through a portionof the housing that surrounds the proximal part of the work tip so as toform a chamber which is in communication with a separate passage in thework tip. The coupler is detachably connected to the connecting body.This allows the removal of the work tip, which becomes a single usepart, so that the rest of the instrument can be reused by replacing thework tip without having to sterilize the connecting body. However, theportion of the housing surrounding the work tip and which forms thechamber for irrigation fluid, also needs to be replaced in this design.

Accordingly a need exists for a surgical hand piece that can provideboth ultrasonic energy to emulsify tissue, cells and other substanceswhich are aspirated by an aspiration fluid and an irrigation liquid thatcan be applied to part of the operating site being cleaned in a moredirectional and controlled manner. Further, it would be beneficial ifthe cleaning were carried out by an A/I tool without ultrasonicvibration, but had a dual lumen structure to create different kinds ofcleaning irrigation patterns and force. In addition, it would bebeneficial if phacoemulsification instruments with dual lumens couldhave their operation varied without withdrawing the instrument from theeye and/or diverting the surgeon's attention from the operating site.This would reduce the chances of infection and trauma.

SUMMARY OF THE INVENTION

In accordance with the invention a surgical hand piece is provided thatcan perform all of the functions of emulsification of tissue and othersubstances by ultrasonic energy, aspiration of such tissue andsubstances, and/or provide a variable directed liquid irrigation of asite that is being worked on in order to clean up the site.

The invention provides a surgical phacoemulsification hand piece thathas a novel work tip having a dual separate side-by-side lumenconstruction, as opposed to the concentric structure of the prior art.The work tip is effectively a unit of two tubes or sections of twotubes. Hereafter the term “tube” refers to a full tube or a section of atube with each such tube or section having its own lumen. Where sectionsof tubes are used at least a portion of such sections are integratedalong a common surface. One of the tubes receives the ultrasonic energyfrom the hand piece and its lumen forms the aspiration passage throughwhich the emulsified tissue and other substances are removed. This tubecan have any desired shape at its working end and any desired shape ofaspiration opening. The irrigation liquid flows through the other tubeand its end can have any number of openings or ports in any desiredpattern to direct the flow of the irrigation fluid.

The novel work tip, whose lumens allow fluid to flow from proximal todistal ends and vice versa, permits switching of the tubes betweenaspiration and irrigation functions so that the surgeon has a work tipwith different types of openings for both irrigation and aspirationfunctions. In different embodiments of the invention, both of the tubesof the work tip can be supplied with ultrasonic energy and either oneused for aspiration or irrigation. Further, the tip may be designed sothat it can be easily exchanged for a new tip and the hand piece putinto service again without having to sterilize it.

The switching of the operation of the lumens can be achieved by manuallyswitching the tubes connected to the irrigation supply and aspirationpump. However, this requires a stop in the procedure while the switch ismade. As an alternative, it is proposed that the system have a rotatingvalve conveniently located on the housing of the aspiration pump. In oneposition the valve causes irrigation fluid to flow through one lumen andaspiration fluid to be withdrawn through the other. Operation of thevalve causes the irrigation and aspiration fluid flow to switch lumens.

Another embodiment mounts the lumens in the hand piece so they can bemanually rotated with respect to the inlet for the irrigation fluid andoutlet for the aspiration fluids. Thus, by rotating a portion of thehand piece which the work tip is still located in the eye reverses thefunctions of the lumens. This is beneficial because it is fast and thesurgeon does not have to take his or her attention away from theoperation site.

The hand piece of the invention has numerous advantages. For example,the need for infusion sleeves within which the irrigation liquid flowsis eliminated. An infusion sleeve is a separate item that needs to beattached to the instrument hand piece. This means that such sleeves haveto be designed and manufactured for a particular hand piece. Also, thesleeves are subject to wear and tear and other complications. Theelimination of the need for an infusion sleeve from the surgical handpiece has economic advantages in that there are fewer parts to dealwith.

The hand piece of the present invention also has a surgical benefit inthat it eliminates the need for the surgeon to remove a work tip fromthe operating site, such as the eye, and to insert a separate work tipor tips having irrigation/aspiration (1/A) capability, in order toperform special procedures, such as cortical and lens epithelialcleanup.

The principals utilized in the surgical hand piece can also beimplemented in an UA tool design with two lumens, which may beside-by-side or concentric. The two lumens provide at least twodifferent irrigation patterns for cleanup. By means of a mechanismwithin the hand piece, the irrigation and aspiration lines can beswitched without having to remove the UA tool from the eye, and withoutthe surgeon having to divert his attention from the eye, e.g., tooperate a switching valve on the aspiration pump.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantage of the present inventionwill become more apparent upon reference to the following specificationand annexed drawings in which:

FIG. 1 is a plan view, partly in cross section, of one embodiment of thesurgical hand piece of the invention;

FIG. 1A is a plan view, partly in cross section, of another embodimentof the surgical hand piece of the invention;

FIG. 2 is an enlarged view of the distal end of the work tip shown inFIG. 1;

FIGS. 3A, 3B, 3C and 3D are cross-sectional views showing various formsof integrated work tips;

FIGS. 4A and 4B are schematic views of a valve arrangement to controlswitching between irrigation and aspiration functions for the tubes ofthe work tip;

FIG. 5 is a view, partly in cross-section, of another embodiment ofsurgical hand piece according to the present invention;

FIG. 6 is a view in cross-section of a prior art type of surgical handpiece;

FIG. 7 is a schematic view of a modification of the work tip accordingto the present invention;

FIG. 8 is a schematic side view of the eye showing a cannula located inthe cornea and a dual lumen work tip positioned to enter the cannula;

FIG. 9 is a top view of the cannula of FIG. 8;

FIG. 10 is an enlarged cross sectional view of the cannula positioned inthe cornea and receiving auxiliary infusion fluid which passes throughit and into the eye;

FIGS. 11A and 11B show alternative auxiliary infusion fluid flow pathsin the cannula of FIG. 8; and

FIG. 12 is a plan view, partly in cross section, of a further embodimentof the surgical hand piece of the invention in which only the work tipand connecting body liners need to be replaced after use.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a first embodiment of the hand piece of the invention. Ituses a number of the components of the prior art type of hand piecedescribed above with respect to FIG. 6. The source of theelectro-mechanical energy is shown schematically by reference number 102and can be either the electromagnetic type as described or thepiezoelectric type. It is preferred, and is conventional, that theoutput power of the source 102 can be controllably varied to set theultrasonic power at the work tip distal end.

Connected to the source 102 is the connecting body 104 within a housing108. A pair of O-rings 112 and 114 spaced apart around the connectingbody 104 and engaging the inner surface of the housing form a firstchamber 118. The first chamber 118 receives aspiration force from a line124 that is connected to a suitable source such as a peristaltic pump.It is preferred that the negative (suction) pressure provided at line124, be controllable. A flow passage 120 is formed in the connectingbody 104 that communicates with the first chamber 118 and extends to thereduced diameter distal end of the connecting body 104.

A second chamber 158 is formed between the O-ring 112 and the distal endof the housing 108. This chamber receives irrigation fluid from a line164 that is connected to a suitable source, such as a bag of salinesolution or a liquid supply having a pump. Here also, it is preferredthat the volume and pressure of the fluid be controllable. The proximalend of a work tip 130 extends through the distal end of the housing 108.A flange hub 152 is connected to an intermediate point of the work tipand the flange abuts against the distal end of the housing 108 and isheld against it by a threaded collar 154. This forms a fluid tight sealat the distal end of the housing and seals the second chamber 158.

The work tip 130 is a unit of two tubes or tubular sections 132 and 134.The two tubes can be of any of the types illustratively shown in FIGS.3A-3D and described below. As illustratively shown, the proximal end ofthe work tip 130 first tube 132 has a coupling 138 that is threaded intothe distal end of the connecting body 104. This places the lumen of thefirst tube 132 in communication with the passage 120 in the connectingbody 104. The tube 132 will also be provided with ultrasonic energy fromthe source 102 through the connecting body 104. At the proximal end ofthe work tip 130 there is a second tube 134, which is open, located inthe housing second chamber 158 and in communication with any fluid inthis chamber. With this arrangement, there is fluid flow to or from eachof the tubes 132 and 134 of the integrated work tip 130. That is,aspiration, flow or liquid flow can be provided from the distal end ofthe first tube 132 through the passage 120 in the connecting body 104,into the first chamber 118 so as to exit at line 124 under suction fromthe aspiration pump. Similarly, irrigation fluid flow can be provided toline 164, to the second housing chamber 158, to the proximal end of thesecond tube 134 to exit at the distal end of tube 134.

FIG. 1A shows a further embodiment in which there is no flow passage inthe connecting body 104. Here, the proximal end of the work tip 130 is agenerally cylindrical hub 135 that receives the proximal ends of thetubes 132 and 134. The tubes can be any of the types described belowwith respect to FIGS. 3A-3D. The proximal end of the hub 135 is ofreduced diameter so that it can be attached such as by threads 138 withthreads in a recess of the distal end of the connecting body 104 whoseproximal end is connected to the source of ultrasonic energy 102. Thehub 135 has respective passages 224 and 264 to the lumen of each of thetubes 132 and 134. The aspiration and irrigation fluids are withdrawn orsupplied, respectively, over the lines 124 and 164 through the hubpassages directly to the lumens of the two tubes. The lines 124 and 164can be inserted directly into the hub passages 224 and 264. A housing128 (shown in dotted line) of a suitable shape is provided over theenergy source 102 and the connecting body 104. In this embodiment, bothtubes 132, 134 receive the ultrasonic energy. As described below, thefluids withdrawn from or supplied to the two tubes can be switched byusing a control valve.

The work tip of FIG. 1A has an advantage in that there is no fluid flowthrough the connecting body 104 or any part of the instrument other thanthe hub 135 and work tip 130 itself. Therefore, they are the only partsof the instrument that can become contaminated if the patient beingoperated on has a malady such as “mad cow/prion” disease. Also, withthis arrangement, while the housing may extend over the energy source102 and the connecting body 104, it need not extend over the hub 135.Thus no fluid chamber is formed by the housing which needs to beexchanged after use. Only the work tip 130 and hub 135 have to besterilized after each use of the instrument or they can be treated as“disposable” and a new work tip and hub can installed each time that theinstrument is used. In order to make the disposability of the work tipmore practical, it can be made, at least in part, of less expensivematerials. For example, a core portion 260 of the hub (shown in dottedline) from connecting body 104 to the tubes 132, 134 and the tubesthemselves may need to be made of a very hard material, e.g., titanium,in order to transmit vibrations of sufficient strength to affect thebreakup of a cataract during its removal. However, a portion of the hubsurrounding the core, the passages 224, 264 and the connectors 124, 164may be made of a less expensive material, e.g., a hard plastic, in orderto reduce its cost.

FIG. 2 shows an illustrative example of the distal ends of the two tubes132 and 134 of the work tip 130. The proximal ends of the tubes aredisposed as shown in FIG. 1 or the inverse of what is shown in FIG. 1Aor in another embodiment as shown in FIG. 5, or by any suitablearrangement such that ultrasonic energy from the transducer andaspiration fluid is coupled to the proximal end of at least one of thetubes and the proximal end of at least one tube can receive theirrigation fluid from its distal end. In this example the first tube 132is intended to be connected to receive the ultrasonic energy from thesource 102 and has a scooped, or concave shaped, opening 162 near itsdistal end to receive the emulsified tissue that is produced byvibrations of the free end of the tube. The opening 162 can be of anydesired shape and size and also can be at the extreme distal end of thetube. The second tube 134 has at least one and preferably a plurality ofopenings 165 through which an irrigation liquid can flow to exit at theoperating site. The number of openings 165 and their pattern can beselected as desired. There can be one or more rows along the tubelength. The openings 165 in tube 134 preferably are oval (elliptical) inshape as shown. Oval shaped openings 165 allow for both good dispersionof the irrigation fluid and a large area for aspiration of cells andsubstances dislodged by the irrigation liquid. The openings 165 also canhave the standard circular hole configuration. As explained below, thehand piece of the invention provides for switching of the functions tobe performed by the two tubes. That is, either tube can be used toperform the irrigation function or the aspiration function.

FIGS. 3A, 3B, 3C and 3D show cross-sections of tubes that can be usedfor the work tip 130. In FIG. 3A two fully circular tubes 132 a and 134a are joined together at the area 135, such as by welding, to form aunitary structure. The joining 135 can be continuous or spaced along thelengths of the two tubes. When two complete tubes are used for the worktip they do not necessarily have to be connected together along theirlengths as shown in FIG. 3A since each tube has its own lumen and doesnot need any part in common with the other tube to have fluid flowtherein. An arrangement of two separate tubes 132 b and 134 b is shownin FIG. 3B. A unitary structure work tip is formed by using a hub or asimilar element to hold the two tubes together as shown in FIGS. 1, 1Aand FIG. 5.

In FIG. 3C two half tube sections 132 c and 134 c are connected to acommon central wall 137 to form a unitary structure. Here an overallsomewhat elliptical tube can be divided into the two tube sections andthen joined to the center common wall 137. In FIG. 3D there is a fullycircular tube 134 d on top of which a part of a circular tube section132 d is joined at 139 along its length, making the work tip a unitarystructure. When two tube sections are used to form the work tip theproximal ends are modified (not shown) to have the appropriate shape,such as fully circular, so as to be able to perform its function such ascoupling to the connecting body to receive ultrasonic energy and toreceive aspiration and irrigation fluid. The distal ends also aremodified to provide fluid flow from and to the aspiration and irrigationopenings.

It should be understood that the two tubes 132 and 134 can be ofdifferent diameters and shapes in addition to the more symmetricalarrangements shown in the drawings. Also, the tubes can be made of anysuitable material, such as titanium or any suitable material which canwithstand the stress of vibration. Both tubes can be of the samematerial, or they can be of different materials. It also may bedesirable to make one of the tubes, for example the one to which theirrigation fluid is usually applied, of a plastic material such asTEFLON®. While a tube of plastic material will not be able to vibrate ifit receives ultrasonic energy, it can still be used to perform both theaspiration and irrigation functions depending upon which fluid issupplied to it. Further, the two tubes 132 and 134 can be of differentlengths.

FIGS. 4A and 4B schematically show a valve arrangement for the supplylines 124 and 164. There is a valve 175 that receives one input from anirrigation liquid source, such as a bag of a saline solution usinggravity feed or from a liquid source under controlled pressure andvolume. The valve second input is from an aspiration source, such as aperistaltic pump, of controlled suction force or pressure. In FIG. 4Athe valve 175 is in a position such that there is irrigation liquid flowis to line 164 meaning that there will be liquid in the second housingchamber 158 of FIG. 1 to be provided to the second tube 134 to flow outof its distal end. The aspiration source will be connected to the line124 so that there will be negative pressure (suction) fluid in the firsthousing chamber 118 that is provided to the distal end of the first tube132 through the passage 120 in the connecting body 104. Thus, fluid willflow from the distal end of tube 132 out of line 124 to the valve andthen to the suction pump. As seen in FIG. 4B, by switching the valve 175the conditions will be reversed so that there will be aspiration flow online 164 causing the second tube 134 to perform an aspirating functionand liquid flow in line 164 causing the first tube 132 to perform anirrigation function. Thus, the tubes 132, 134 are capable of fluid flowin either direction, depending on the function they are performing.

FIG. 5 shows another embodiment of the invention for coupling the worktip 130 to the hand piece. The same reference numbers are used for thesame components of FIG. 1. Here there are two passages 120 and 180 in aconnecting body 204. One end, the proximal end, of passage 120 is incommunication with the irrigation fluid input of the supply line 124.The proximal end of passage 180 is in communication with the aspirationfluid of the supply line 164. The distal ends of the two passages 120and 180 terminate at the distal end of the connecting body 204.

There are threads 182 around the connecting body distal end. A hub 190is around the proximal ends of the work tip tubes 132 and 134 which arebent so that the proximal ends of their lumens are parallel to thedistal ends of the connecting body passages 120 and 180. A collar 194with internal threads on its open end has its flange end rotatablymounted in a groove 192 in the hub 190. There are mating index pieces,such as mating grooves and ribs or pins (not shown), on the opposingfaces of the connecting body 204 distal end and the hub 190 so that theproximal end of the lumen of tube 132 will be aligned with the distalend of connecting body passage 120 and the proximal end of the lumen oftube 134 aligned with the distal end of passage 180. Other types ofalignment pieces and markings can be used. When the tubes and connectingbody are properly aligned the collar 194 is tightened on the connectingbody threads 182 and the lumens at the proximal ends of tubes 132 and134 will be brought into fluid communication with the distal ends of theconnecting body passages 120 and 180. O-rings 193 are provided in theconnecting body at the distal ends of passages 120 and 180 to make thecommunication fluid tight.

In this embodiment of the invention, both of the tubes 132, 134 receivethe ultrasonic energy from the source 102. The valve 175 of FIG. 4 canbe used with the hand piece of FIG. 5 to switch the fluid flow from thesources 124 and 164 to the lumens of tubes 132 and 134 of the integratedwork tip. Since both tubes 132 and 134 receive ultrasonic energy theemulsification of tissue and its aspiration can take place througheither one in addition to each tube being able to supply irrigationliquid through the different types and shapes of openings at the distalends of the tubes.

A still further embodiment of a work tip for a hand piece according tothe present invention is shown in FIG. 12. As seen in FIG. 12 theconnecting body 204 has passages 120, 180 as in the embodiment of FIG.5. However, in FIG. 12 the connecting body has a narrow section 205 onwhich there are the threads 182. Tubes 132 and 134 abut this narrowsection of the connecting body. A threaded collar 195 is slide over thetubes and engages the threads 182. The narrow portion 205 of theconnecting body and the tubes have alignment pieces (not shown) so thatpassages 120, 180 are aligned with the lumens in the tubes 132, 134.Further, the tubes 132, 134 have proximal flanges that fits within thecollar 195 so that when the collar is tightened onto the threads 182 ofthe narrow part 205 of the connecting body, a tight stable connection ismade between the tubes and body.

Plastic disposable tubes 324, 364 are provided. These disposable tubescan be inserted into the passages 120, 180 until their distal ends enterthe two work tip tubes 132, 134. As a result, the tubes are made of aflexible material so that they can bend along the passages 120, 180. Theproximal ends of tubes 132, 134 have O-rings or other sealing typeopenings which are made of a material softer than the disposable tubesso that these tubes can push through the seals into the tubes 132, 134and form a fluid tight connection with them. Such seals can be of thetype shown in FIG. 5, except they are located in the tubes 132, 134,instead of the connecting piece 204. The ends of the disposable tubeshave connector 325, 365 at their proximal ends for connection to thesource of irrigation fluid or aspiration vacuum.

When the hand piece is used in its intended fashion and the procedure isover, the hand pieces can be quickly readied for use on another patientwithout the need for sterilization. In particular, the collar 195 isloosened. Then the working tip with tubes 132, 134 is disposed of. Inaddition, tubes 324, 364 are also disposed of. Each of these sets oftubes is replaced with clean, pre-sterilized tubes, and the hand pieceis ready for the next use. This is possible because the only parts ofthe hand piece that come into contact with the aspiration fluid from thepatient are the interiors of the tubes 132, 134 and 324, 364. As notedwith respect to the embodiment of FIG. 5, it may be useful in terms ofexpense to make the tubes 132, 134 of a material that is hard, but notas expensive as titanium, so as to be able to transmit the vibrationforce. The tubes 324, 364 do not have to transmit the vibration force,so they can readily be made of a plastic material such as TEFLON®, as away of reducing the cost of the disposable parts of the hand piece.

The work tips of the invention, such as illustratively shown in FIGS. 1,1A, 5 and 12, can be used with only an irrigation/aspiration (1/A)function. That is, the source of ultrasonic energy can be turned off andonly the aspiration and irrigation fluids supplied to the tubes 132 and134. Also, the aspiration force is lowered, e.g., from 500 mm Hg to 5-10mm Hg during the cleaning operation so that the posterior capsule tissueat the back of the eye is not drawn into the tube. Here also the valvearrangement of FIG. 4 can be used so that either of the tubes canreceive aspirated tissue or supply irrigation fluid. However, it may bepreferable to utilize the tube with the small circular holes 165 forthis cleaning procedure, again to avoid aspirating the posterior capsuletissue. Thus, the same instrument can be used for thephacoemulsification function while performing irrigation and aspirationas an operation takes place and also only for I/A functions (noultrasonic energy is used) useful for cleaning the capsular bag asdescribed above. This eliminates the need for the surgeon changinginstruments and also provides the surgeon with a working tip having twotubes with different shape openings available for both aspiration andirrigation.

Following the above, only one of the tubes can be used only as an I/Aworking tip. That is, it does not receive ultrasonic energy. This isshown in FIG. 7 in which the tube 234 follows the general format of thetube 134 of FIG. 2. That is, it has the oval openings 165 along the tubelength. It receives either irrigation or aspiration fluid from sources210 and 212 at its proximal end through a valve 275. The tube 234 can beused alone in the eye capsular bag for the substance and cell cleanupprocedure described above. The oval shaped openings 165 allow for bothgood dispersion of the irrigation fluid and a large area for aspirationof cells and substances dislodged by the irrigation liquid.

In each of the embodiments described a support member can be mountedaround the work tip 130 to rest against the eye when the work tip isinserted in the eye. For example, a cannula can be inserted into theincision site and then the work tip 130 can be placed into the cannula.This cannula provides ⋅ thermal insulation at the incision sight inorder to protect the eye from any heat generated by the vibration ofwork tip 130. This arrangement is shown in FIG. 8.

As noted above, FIG. 1A illustrates a surgical hand piece with a singleuse work tip 130. FIG. 8 is a schematic side view of the eye 300 of apatient showing the dual lumen work tip 130 (not to scale) positioned toenter a surgical opening made in the cornea 302 of the eye during aprocedure to remove cataracts 304 from the eye by phacoemulsification.The work tip enters the eye through a cannula 310 adapted to fit in theopening. Once in the vicinity of the cataract, the ultrasonic vibrationof the work tip 130 causes the cataract to break up into small pieceswhich can be aspirated through one of the tubes 132, 134. In addition tothe pieces of cataract, some of the fluid in the eye is also removedduring the aspiration. If too much fluid is removed, the cornea cancollapse, complicating the procedure and possibly damaging the eye. Asnoted above, fluid can be replaced by injecting it into the other tubeof the work piece.

The cannula is generally cylindrical in shape. As best seen in the topview of FIG. 9, the cannula has a large outer flange 311 which keeps itfrom completely entering the eye. Also, it has a small flange orprotrusions 313 on the part adjacent the interior surface of the corneain order to anchor the cannula in place between the two flanges. Thesesmall protrusions or flanges are located circumferentially around thecylindrical shape and must not be too large because they are pressedinto the opening in the cornea and stretch it slightly as they enter theeye. However, they do not stretch it so much that it damages the cornealtissue surrounding the opening.

The housing 128 for the surgical piece as shown in FIG. 1A, as is alsodepicted in FIGS. 8 and 10. Housing 128 covers the source of theelectro-mechanical energy 102 and the connecting body 104. However, thework tip 130 is not within the housing, which facilitates easy exchangeof work tips. As a result, the ultrasonically vibrating work tip 130 isexposed. The cannula 310 protects the corneal tissue surrounding theopening from friction caused by this vibration. In order to assist infriction reduction the cannula can be made of a low friction materialsuch as TEFLON®.

In order to further protect the cornea from the heat generated byfriction from the vibrating work piece, the cannula can be provided withcooling fluid as shown in FIG. 8 and in more detail in enlarged FIG. 10.The cannula 310 can be connected to an infusion line 400. Within thecannula there is a cylindrical channel 314 so that the fluid from line400 completely surrounds the interior of the cannula and cools its outersurface, which engages the cornea 302. The fluid can exit the cannulawithin the eye as auxiliary irrigation fluid though a circular exit 315as best shown in FIG. 11A. However, as an alternative or in addition tothe circular exit 315 there may be provided a series of holes 318 asshown in FIG. 11B.

If the infusion fluid from the work tip 130 is too little, it can becompensated for by the auxiliary fluid infused through the cannula. Ifthe amount is too much, either because of the work tip and/or thecannula, the central opening in the cannula through which the work tipextends is sufficiently wide that the work tip does not block it and theextra fluid can pass out of the eye around the work tip.

While the invention has been shown and described in connection with theremoval of cataract from the eye of a patient, the apparatus and methodmay also be used for other types of surgery in other parts of the body,e.g., the removal of neurological tissue.

Specific features of the invention are shown in one or more of thedrawings for convenience only, as each feature may be combined withother features in accordance with the invention. Alternative embodimentswill be recognized by those skilled in the art and are intended to beincluded within the scope of the claims. Accordingly, the abovedescription should be construed as illustrating and not limiting thescope of the invention. All such obvious changes and modifications arewithin the patented scope of the appended claims.

I claim:
 1. A surgical hand piece comprising: a source of ultrasonicenergy; a connecting body having a proximal end connected to saidultrasonic energy source and a distal end; and a work tip having aproximal hub from which extend at least first and second tubes alignedside by side and adjacent to each other, said hub having first andsecond external openings, each of said tubes having a proximal endconnected to separate passages in said hub leading to the externalopenings, said work tip being detachably connected to said connectingbody distal end and being of a material suitable for conveying theultrasonic energy from said ultrasonic energy source to the distal endof said tubes, wherein ultrasonic energy may be transmitted from saidsource of ultrasonic energy through said connecting body to said hub inorder to ultrasonically vibrate both said at least first and secondtubes, wherein each of said at least first and second tubes has a lumenthat is to receive or discharge a fluid at its proximal end from one offirst and second fluid sources that are respectively irrigation andaspiration fluids, the lumen of each of said at least first and secondtubes being separate and spaced apart, and each tube of said at leastfirst and second tubes having an opening at its distal end through whichthe fluid received at or discharged from the proximal end of therespective lumen of each tube of said at least first and second tubesexits from or enters the tube, with each said tube distal end openingbeing separate, independent of, spaced from and without being incommunication with the distal end opening of the other tube, aspirationfluid flow being in one of said at least first and second tubes andirrigation fluid flow being in the other, and said aspiration andirrigation fluid flows being selectively and alternately reversible insaid tubes.
 2. The surgical hand piece according to claim 1 wherein thefirst and second external openings are on opposite sides of the hub andare at an angle to the respective tubes.
 3. The surgical hand pieceaccording to claim 1 further including a valve to receive the fluidsfrom the first source and discharge fluid to the second source and forswitching the received and discharged fluids respectively to be suppliedto or received from the respective lumen of either one of said at leastfirst and second tubes, wherein the respective lumen of each of said atleast first and second tubes can receive or discharge the fluid fromeither one of said first and second sources as switched by said valve.4. The surgical hand piece according to claim 1 wherein one of the atleast first and second tubes has a distal opening that is larger thanthe distal opening of the other.
 5. The surgical hand piece according toclaim 4 wherein the tube with the larger distal opening has a singleopening with a concave shape and the tube with the other distal openinghas a plurality of small oval shaped openings.
 6. The surgical handpiece according to claim 1 wherein said work tip is detachably connectedto said connecting body distal end by a threaded connection.
 7. Thesurgical hand piece according to claim 1 wherein said at least first andsecond tubes have about the same diameter and nearly the same lengthafter leaving the hub to facilitate their being used for eitheraspiration or irrigation.